Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain

Обзор

The purpose of the research study entitled "Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients with Chronic Lower Back Pain" is to investigate the hypothesis that combined treatment with both osteopathic manipulative medicine (OMM) and phototherapy will provide greater pain relief for patients with chronic lower back pain, as compared with standard medical management or either treatment alone.

Подробное описание

The research has demonstrated separately that phototherapy and osteopathic manipulative medicine (OMM) are effective in reducing chronic low back pain, However there has not been any research to evaluate whether the interaction of the two treatment approaches together can provide enhanced pain relief. In A Meta-analysis of the Efficacy of Phototherapy in Tissue Repair, Fulop et.al.(1) from the Department of Physical Therapy, School of Health Professions, New York Institute of Technology (NYIT) concluded that "phototherapy is a highly effective form of treatment for tissue repair, with stronger supporting evidence resulting from experimental animal studies than human studies" (Fulop, p. 695, 699). Further review of the literature by Fulop et. al. (2) focused on the question of pain relief in relation to phototherapy, and the conclusion was that pain from various etiologies can be effectively relieved by phototherapy. The U.S. Food and Drug Administration has cleared biostimulation lasers (a.k.a. low level laser therapy \[LLLT\], cold lasers, soft lasers, or laser acupuncture devices) for marketing as "adjunctive devices for the temporary relief of pain" (3). Thus, both health practitioners and the lay public have access to and may potentially obtain and use phototherapy devices manufactured by various companies. Other research protocols by Gur, A et. al. (4) and Djavid, GE et. al. (5) evaluated patients with chronic low back pain in relation to the combined effectiveness of low level laser therapy and exercise. These studies showed positive results with the combined approaches.

Osteopathic physicians utilize an approach to the treatment of patients called osteopathic manipulative medicine (OMM). The osteopathic physician will diagnose somatic dysfunction, and then treat the dysfunctions found with one or more of several OMM treatment approaches. The American Osteopathic Association (AOA) published in 2009 the "Guidelines for Osteopathic Manipulative Treatment (OMT) for Patients with Low Back Pain." These guidelines are available both through the AOA and the Agency for Healthcare Research and Quality (AHRQ), National Guideline Clearinghouse (6). This guideline (6) specifically addresses the "efficacy of osteopathic manipulation treatment in reducing low back pain" (p. 2). A review of the literature was performed, and after selection a total of "six trials, involving eight osteopathic manipulative treatment (OMT) vs control treatment comparisons, were included" in the meta-analysis (p. 2-3). The major recommendation stated in the guideline is that "osteopathic manipulative treatment (OMT) be utilized by osteopathic physicians for musculoskeletal causes of back pain, i.e., to treat the diagnoses of somatic dysfunctions related to the low back pain" (p.4). In addition, the meta-analysis performed did show that OMT for patients with low back pain led to statistically significant reduction in pain (p. 5). Thus, the potential for a complementary approach to patient care in cases of chronic low back pain exists. Yet, no studies to date have specifically evaluated this particular hypothesis regarding OMT and phototherapy for patients with chronic low back pain. The purpose of this research is to evaluate this question of enhanced combined efficacy for the overall benefit of patients.

Вмешательства

• Процедура Osteopathic Manipulative Medicine
• Процедура Phototherapy

Первичные конечные точки

• 10 cm visual analog scale for quantitative back pain [Срок оценки: 8 weeks]
• SF-36 Health Survey to measure Quality of Life [Срок оценки: 8 weeks]
• The Oswestry Back Questionnaire to measure qualitative back pain [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• Age range: 18 - 65 years old
• Subjects with constant or intermittent nonspecific lower back pain for a minimum of three (3) months duration.

Критерии исключения

• Prospective subjects with a diagnosis of the following potential underlying causes of lower back pain: ankylosing spondylitis, cancer or a history of a histologically demonstrated malignant carcinoma, cauda equine syndrome, herniated disc, spinal fracture, or spinal osteomyelitis.
• Prospective subjects who have undergone surgery of the lower back in the preceding three (3) months.
• Prospective subjects who have received worker's compensation in the preceding three (3) months, or are involved in litigation involving concerns of lower back.
• Prospective subjects who are pregnant.
• Prospective subjects who have been a patient receiving any osteopathic manipulative medicine (OMM) treatment at the clinical trial site in the previous three (3) months, or on greater than three (3) occasions in the preceding year.
• Prospective subjects who have ever been an employee at the clinical trial site.
• Prospective subjects who have received spinal manipulation in the previous three (3) months, or on greater than three (3) occasions in the preceding year.
• Prospective subjects who are currently involved in a physical therapy rehabilitation program.
• Prospective subjects who have photosensitivity.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• New York Institute of Technology — Old Westbury

Публикации

• Fulop AM, Dhimmer S, Deluca JR, Johanson DD, Lenz RV, Patel KB, Douris PC, Enwemeka CS. A meta-analysis of the efficacy of phototherapy in tissue repair. Photomed Laser Surg. 2009 Oct;27(5):695-702. doi: 10.1089/pho.2009.2550. PMID 19698019
• Gur A, Karakoc M, Cevik R, Nas K, Sarac AJ, Karakoc M. Efficacy of low power laser therapy and exercise on pain and functions in chronic low back pain. Lasers Surg Med. 2003;32(3):233-8. doi: 10.1002/lsm.10134. PMID 12605431
• Djavid GE, Mehrdad R, Ghasemi M, Hasan-Zadeh H, Sotoodeh-Manesh A, Pouryaghoub G. In chronic low back pain, low level laser therapy combined with exercise is more beneficial than exercise alone in the long term: a randomised trial. Aust J Physiother. 2007;53(3):155-60. doi: 10.1016/s0004-9514(07)70022-3. PMID 17725472
• Licciardone JC, Stoll ST, Fulda KG, Russo DP, Siu J, Winn W, Swift J Jr. Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2003 Jul 1;28(13):1355-62. doi: 10.1097/01.BRS.0000067110.61471.7D. PMID 12838090
• Williams NH, Wilkinson C, Russell I, Edwards RT, Hibbs R, Linck P, Muntz R. Randomized osteopathic manipulation study (ROMANS): pragmatic trial for spinal pain in primary care. Fam Pract. 2003 Dec;20(6):662-9. doi: 10.1093/fampra/cmg607. PMID 14701889
• Williams N. Managing back pain in general practice--is osteopathy the new paradigm? Br J Gen Pract. 1997 Oct;47(423):653-5. PMID 9474832
• Ferreira ML, Ferreira PH, Latimer J, Herbert RD, Hodges PW, Jennings MD, Maher CG, Refshauge KM. Comparison of general exercise, motor control exercise and spinal manipulative therapy for chronic low back pain: A randomized trial. Pain. 2007 Sep;131(1-2):31-7. doi: 10.1016/j.pain.2006.12.008. Epub 2007 Jan 23. PMID 17250965
• Burton AK, McClune TD, Clarke RD, Main CJ. Long-term follow-up of patients with low back pain attending for manipulative care: outcomes and predictors. Man Ther. 2004 Feb;9(1):30-5. doi: 10.1016/s1356-689x(03)00052-3. PMID 14723859

Идентификаторы

NCT: NCT01765777 · BHS-740

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗